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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCORONARY FLEXTOME CUTTING BALLOON
Generic Namecatheter, transluminal coronary angioplasty, percutaneous
ApplicantBOSTON SCIENTIFIC
PMA NumberP950020
Supplement NumberS047
Date Received11/07/2011
Decision Date12/07/2011
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the manufacturing process equipment by implementing an alternate bioslide coating machine, with updated hardware, software, and processing changes, as well as a minor rearrangement of the existing production equipment to new locations within the current manufacturing line.
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